Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2362-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

Product Classification:

Class II

Date Initiated: June 13, 2023

Date Posted: August 16, 2023

Recall Number: Z-2362-2023

Event ID: 92650

Reason for Recall:

Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

Status: Ongoing

Product Quantity: 37 US 194 PR

Code Information:

Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.

Distribution Pattern:

US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated